FDA Launches the

Pharmaceutical CommercePharmaceutical Commerce - January/February 2009

100 applicants are sought to join voluntary effort in promoting drug safety

Call it the revenge of the pig intestines (which figured to some degree in the contaminated heparin scandal from a year ago): Just as the top leadership of FDA is leaving the door with the arrival of a new White House administration, the agency has posted a Federal Register Notice for a “Secure Supply Chain” pilot program. The stated goal: “to allow FDA to determine the practicality of developing a secure supply chain program” and to “assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements.”

The program is the culmination, of sorts, of the Bush Administration’s Interagency Working Group on Import Safety. It has input from the Customs and Border Patrol (CBP) unit of the Dept. of Homeland Security.

According to the FR notice, up to 100 applicants, each with up to five drugs, will enter the pilot after filing an application that is reviewed by FDA. Holders of valid NDAs or ANDAs for drugs and APIs are eligible; the companies must also already vetted by the

Customs-Trade Partnership Against Terrorism

(C-TPAT) program, which was set up by Customs in the aftermath of 9/11. Brokers, carriers and other supply chain participants must be likewise certified. FDA plans to review documentation of participants over the duration of the pilot and, one assumes, identify weak points or flaws that could then be addressed by regulation in the future.

The one incentive for participating that FDA is explicit about: to “increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United States that meet the criteria for selection under the program.” This is a feature very similar to that offered by C-TPAT when it was started up, and now C-TPAT-compliance companies get some benefit at border crossings.

Pharmaceutical Commerce will be looking more closely at this program, which on the one hand addresses some glaring shortfalls in current trade and supply chain practices, but in other ways highlights FDA’s inability to do what it is already required to manage under current regulations. Just about every week, FDA routinely sends recall notices for food supplements, health products and, in some cases, pharmaceutical products being imported without sufficient safeguards. There are thousands of manufacturing facilities outside the U.S. that have yet to be visited by an FDA inspector (which was one of the problems with the heparin incident). And although FDA says that the program will help address the importation of “adulterated, misbranded or unapproved drugs,” the program doesn’t seem to link into FDA’s other supply-chain security initiative, the Counterfeit Drug Task Force.

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